Why is a formal CAPA management process needed?
- To allow to formal control over all occurring issues and to prevent their re-occurrence
Audit observations: What was missing?
- Absence of a formal/clear process for the management of non-conformities and for capturing CAPAs (corrective and preventive measures)
- no CAPAs are assigned and followed up or process description lacks clarity
- Limited assessment and implementation of preventive actions (lack of effectiveness check).
Recommendations:
- write a procedure that defines the documentation and handling of non-conformities, the respective responsibilities
- define how root cause analyses are conducted to ensure that adequate corrective as well as preventive measures are taken to eliminate and prevent the errors in the future.
- formalize a process including:
- The documentation and management of non-conformities and potential non-conformities
- Determining causes for (potential) non-conformities (root cause analysis)
- A risk analysis, assessing the impact of the non-conformity and justifying the defined measures (e.g. in case of minor non-conformities evaluating the need for corrective and preventive actions)
- The relevance for the affected, general processes (system level)
- The definition of corrective and preventive measures; the respective responsible person(s); the required timelines for measure completion (due dates)
- The follow-up of measure completion
- The effectiveness of the defined measures (follow-up observation), if necessary
- Definition of the classification and the terminologies used to describe and evaluate non-conformances
- implement a template or form for the recording of the non-conformances, root cause analysis and CAPAs. Necessary signatures should be obtained on the document to demonstrate ownership of assigned CAPA tasks.